Norclut indications
Norclut Tablets, USP
Norclut tablets, USP are indicated for the treatment of secondary amenorrhea, endometriosis, and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer. Norclut tablets, USP are not intended, recommended or approved to be used with concomitant estrogen therapy in postmenopausal women for endometrial protection.
Uses of Norclut in details
Norclut is a man-made form of progesterone, a naturally occurring female sex hormone. It has a number of uses:
- Low-strength progesterone is used in oral contraceptive pill to prevent pregnancy.
- Medium-strength progesterone is used, to treat irregular, painful or heavy periods, to treat endometriosis (where tissue from the lining of the womb is present in places where it is not normally found), to treat premenstrual syndrome (also known as premenstrual tension, PMS or PMT), to delay periods.
Norclut description
Norclut (INN, BAN), also known as Norethindrone (USAN), is a synthetic progestational hormone with actions similar to those of progesterone but functioning as a more potent inhibitor of ovulation. It has weak estrogenic and androgenic properties. The hormone has been used in treating amenorrhea, functional uterine bleeding, endometriosis, and for contraception.
Norclut dosage
Norclut Tablets
Therapy with Norclut tablets must be adapted to the specific indications and therapeutic response of the individual patient.
Secondary Amenorrhea, Abnormal Uterine Bleeding due to Hormonal Imbalance in the Absence of Organic Pathology
2.5 to 10 mg Norclut tablets may be given daily for 5 to 10 days to produce secretory transformation of an endometrium that has been adequately primed with either endogenous or exogenous estrogen.
Progestin withdrawal bleeding usually occurs within three to seven days after discontinuing Norclut tablets therapy. Patients with a past history of recurrent episodes of abnormal uterine bleeding may benefit from planned menstrual cycling with Norclut tablets.
Endometriosis
Initial daily dosage of 5 mg Norclut tablets for two weeks. Dosage should be increased by 2.5 mg per day every two weeks until 15 mg per day of Norclut tablets is reached. Therapy may be held at this level for six to nine months or until annoying breakthrough bleeding demands temporary termination.
Norclut interactions
If a woman on Norclut takes a drug or herbal product that induces an enzyme(s) that metabolizes Norclut, particularly CYP3A4, the patient should be counseled to use additional contraception or a different method of contraception. Drugs or herbal products that induce such enzymes may decrease the plasma concentrations of Norclut and may decrease the effectiveness of Norclut or increase breakthrough bleeding. Some drugs or herbal products that may decrease the effectiveness of hormonal contraceptives include: Some anti-epileptics (eg, carbamazepine, phenytoin), (fos)aprepitant, barbiturates, bosentan, griseofulvin, some (combinations of) HIV protease inhibitors (eg, nelfinavir, some ritonavir-boosted protease inhibitors), some non-nucleoside reverse transcriptase inhibitors (eg, nevirapine), rifampin and rifabutin, St. John's Wort.
In vitro studies suggest that activated charcoal binds to Norclut, however the therapeutic effect of Norclut is not affected when activated charcoal is administered 3 hrs after the previous dose or 12 hrs before the next dose.
Physicians are advised to consult the labeling of concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations and the possible need to adjust dosages.
Laboratory Tests: Certain endocrine and liver function tests and blood components may be affected by progestin-only oral contraceptive use: Sex hormone-binding globulin concentrations may be decreased; thyroxine concentrations may be decreased, due to a decrease in thyroxine binding globulin. Incompatibilities:
Norclut side effects
Throughout this section, adverse reactions are presented. Adverse reactions are adverse events that were considered to be reasonably associated with the use of Norclut based on the comprehensive assessment of the available adverse event information. A causal relationship with Norclut usually cannot be reliably established in individual cases. Further, because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Clinical Trial Data: The safety of Norclut was evaluated in 3099 subjects in 2 clinical trials. Of these, 2925 subjects participated in a clinical trial of Norclut 0.35 mg administered daily and 174 subjects participated in a clinical trial of Norclut 0.35 mg/day administered on 21 days/cycle. Adverse reactions reported for ≥1% of Norclut-treated subjects are shown in the table.
Adverse reactions reported by <1% of Norclut-treated subjects (N=3099) in the previously stated clinical trials are as follows: Psychiatric Disorders: Depression, nervousness. Gastrointestinal Disorders: Gastrointestinal disorder. Skin and Subcutaneous Tissue Disorders: Acne, hirsutism. Musculoskeletal and Connective Tissue Disorders: Pain in extremity. Reproductive System and Breast Disorders: Genital discharge. General Disorders and Administration Site Conditions: Edema.
Post-Marketing Data: Adverse reactions 1st identified during post-marketing experience with Norclut are included as follows. The frequencies are provided according to the following convention: Very common ≥1/10; common ≥1/100 and <1/10; uncommon ≥1/1000 and <1/100; rare ≥1/10,000, <1/1000; very rare <1/10,000, including isolated reports; unknown (cannot be estimated from the available data).
Adverse reactions are presented by frequency category based on spontaneous reporting rates.
Immune System Disorders: Very rare: Anaphylactic/anaphylactoid reaction, hypersensitivity.
Gastrointestinal Disorders: Very rare: Abdominal pain.
Hepatobiliary Disorders: Very rare: Hepatitis, cholestatic jaundice.
Skin and Subcutaneous Tissue Disorders: Very rare: Alopecia, rash, pruritic rash.
Pregnancy, Puerperium and Perinatal Conditions: Very rare: Ectopic pregnancy.
Reproductive System and Breast Disorders: Very rare: Breast pain, delayed menstruation, irregular menstruation, ovarian cyst, suppressed lactation, vaginal hemorrhage, menorrhagia, withdrawal bleeding when Norclut is stopped.
Norclut contraindications
Hypersensitivity to any component of Norclut. Known or suspected carcinoma of the breast; benign or malignant liver tumor; acute or chronic hepatocellular disease with abnormal liver function; undiagnosed abnormal genital bleeding.
Use in pregnancy: Norclut is contraindicated during pregnancy.
Many studies have found no effects on fetal development associated with long-term use of contraceptive doses of oral progestins. The few studies of infant growth and development that have been conducted have not demonstrated significant adverse effects. Suspected pregnancy should be ruled out before initiating any hormonal contraceptive use.
Active ingredient matches for Norclut:
Norethisterone in Malaysia.
List of Norclut substitutes (brand and generic names) | Sort by popularity |
| Unit description / dosage (Manufacturer) | Price, USD |
| Norate-A (India) | |
| NORATE-A tab 5 mg x 10's (Dewcare) | $ 0.63 |
| Norcolut (Bangladesh, Georgia, Hong Kong, Hungary, Lithuania, Singapore, Vietnam) | |
| Tablet; Oral; Norethindrone 5 mg (Gedeon Richter) | |
| Norcolut 5mg - 20 Tablets (Gedeon Richter) | $ 9.40 |
| Norcolut 5 mg x 20's (Gedeon Richter) | $ 1.14 |
| Norcolut 5 mg x 2 Blister x 10 Tablet (Gedeon Richter) | |
| Norcolut 5 mg x 2 x 10's (Gedeon Richter) | $ 42.00 |
| Norcolut tab 5 mg 20's (Gedeon Richter) | $ 4.30 |
| Norcolut 5 mg (Hungary) | |
| Norcutin (Bangladesh) | |
| Norcutin 5 mg x 1's | |
| Norcutin 5 mg x 50 x 10's | |
| Norcutin 5 mg x 500's | |
| NORDART (India) | |
| NORDART tab 5 mg x 10's (Intra (Intra Life)) | $ 0.61 |
| Nordiropin Simplex (India) | |
| Nordiropin Simplex 5mg INJ / 1.5ml (Novo Nordisk) | |
| NORDIROPIN SIMPLEX inj 5 mg x 1.5ml (Novo Nordisk) | |
| Nordron (Taiwan) | |
| Nordron 5 mg | |
| Noregyna (Brazil) | |
| Norelut (Indonesia) | |
| Norelut 5 mg x 5 x 10's (Dexa Medica) | $ 19.53 |
| Noret (Argentina) | |
| Noreta HRT (India) | |
| Noreta HRT 1mg TAB / 10 (German Remedies (Zydus Cadila Healthcare Ltd.)) | $ 0.17 |
| 1 mg x 10's (German Remedies (Zydus Cadila Healthcare Ltd.)) | $ 0.17 |
| Noreta HRT 1 mg Tablet (German Remedies (Zydus Cadila Healthcare Ltd.)) | $ 0.01 |
| NORETA-HRT (India) | |
| NORETA-HRT tab 1 mg x 10's (Zydus (G.Rem)) | $ 0.17 |
| Noreth | |
| Noreth 5 mg Tablet (Taurus Laboratories Pvt. Ltd.) | $ 0.04 |
| NORETHEA | |
| NORETHEA TABLET 1 strip / 10 tablets each (Orchid Chemicals & Pharmaceuticals Ltd) | $ 0.59 |
| Norethindrone Acetate | |
| Norethindrone Acetate tablet 5 mg/1 (Av Pak (US)) | |
| Norethindrone Acetate Barr (United States) | |
| Norethindrone Lupin (United States) | |
| Norethisteron Jenapharm (Germany) | |
| Norethisteron Slovakofarma (Czech Republic) | |
| Norethisteron Zentiva (Czech Republic, Slovakia) | |
| Norethisterone (Argentina, Austria, Belgium, Bulgaria, Canada, Chile, China, Croatia (Hrvatska), Czech Republic, Denmark, Estonia, Finland, France, Germany, Hong Kong, Hungary, Iceland, Ireland, Israel, Italy, Latvia, Lithuania, Malaysia, Malta, Netherlands, Norway, Oman, Poland, Portugal, Romania, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey) | |
| Tablet; Oral; Norethindrone 5 mg (Atoz Pharmaceuticals (Zota Healthcare Pvt Ltd)) | |
| 5 mg x 10's (Atoz Pharmaceuticals (Zota Healthcare Pvt Ltd)) | $ 0.48 |
| Norethisterone 5 mg Tablet (Atoz Pharmaceuticals (Zota Healthcare Pvt Ltd)) | $ 0.05 |
| Norethisterone 5mg TAB / 10 (Atoz Pharmaceuticals (Zota Healthcare Pvt Ltd)) | $ 0.48 |
| NORETHISTERONE / ATOZ tab 5 mg x 10's (Atoz Pharmaceuticals (Zota Healthcare Pvt Ltd)) | $ 0.48 |
| Ovcon-35 / 28 28 0.4-35 mg-mcg tablet Disp Pack (Atoz Pharmaceuticals (Zota Healthcare Pvt Ltd)) | $ 89.09 |
| Ovcon-50 28 50-1 mcg-mg tablet Disp Pack (Atoz Pharmaceuticals (Zota Healthcare Pvt Ltd)) | $ 89.09 |
| Loestrin 1.5/30 / 21 21 1.5-30 mg-mcg tablet Disp Pack (Atoz Pharmaceuticals (Zota Healthcare Pvt Ltd)) | $ 79.32 |
| Loestrin 1/20 / 21 21 1-20 mg-mcg tablet Disp Pack (Atoz Pharmaceuticals (Zota Healthcare Pvt Ltd)) | $ 79.32 |
| Loestrin Fe 1/20 28 1-20 mg-mcg tablet Disp Pack (Atoz Pharmaceuticals (Zota Healthcare Pvt Ltd)) | $ 79.32 |
| Loestrin Fe 1.5/30 28 1.5-30 mg-mcg tablet Disp Pack (Atoz Pharmaceuticals (Zota Healthcare Pvt Ltd)) | $ 77.10 |
| Loestrin 24 Fe 28 1-20 mg-mcg tablet Disp Pack (Atoz Pharmaceuticals (Zota Healthcare Pvt Ltd)) | $ 75.15 |
See 571 substitutes for Norclut | |
Reviews
The results of a survey conducted on ndrugs.com for Norclut are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Norclut. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
Consumer reported useful
No survey data has been collected yet1 consumer reported price estimates
Was the price you paid to purchase the drug reasonable? Did you feel it was expensive?The below mentioned numbers have been reported by ndrugs.com website users about whether the Norclut drug is expensive or inexpensive. There is a mixed opinion among users. The rating about the cost of the drug depends on factors like which brand drug the patient purchased, how effective it was for the price paid, the country or place the drug is marketed, and the economic condition of the patient. The users who feel the drug is expensive can look for an alternative brand drug or a generic drug to save the cost.
| Users | % | ||
|---|---|---|---|
| Not expensive | 1 | 100.0% | |
Consumer reported time for results
No survey data has been collected yet1 consumer reported age
| Users | % | ||
|---|---|---|---|
| 16-29 | 1 | 100.0% | |
Consumer reviews
There are no reviews yet. Be the first to write one! |
Information checked by Dr. Sachin Kumar, MD Pharmacology
